Trandolapril and Verapamil Hydrochloride 1 mg/1
Trandolapril and Verapamil Hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Glenmark Pharmaceuticals Inc., USA
Trandolapril and Verapamil Hydrochloride is a tablet, film coated, extended release containing trandolapril and verapamil hydrochloride at 1 mg/1, taken oral. Manufactured by Glenmark Pharmaceuticals Inc., USA.
Key Facts
- Brand Name
- Trandolapril and Verapamil Hydrochloride
- Generic Name
- Trandolapril and Verapamil Hydrochloride
- NDC Code (Product)
68462-294- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Strength
- 1 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA079135
- Drug Class
- Angiotensin Converting Enzyme Inhibitor [EPC]
- Marketing Start
- 02/25/2015
Recall History
Glenmark Pharmaceuticals Inc., USA
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Trandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using trandolapril and verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see WARNINGS - Neutropenia/Agranulocytosis ).
Dosage & Administration
DOSAGE AND ADMINISTRATION The recommended usual dosage range of trandolapril for hypertension is 1 to 4 mg per day administered in a single dose or two divided doses. The recommended usual dosage range of verapamil hydrochloride sustained-release tablets for hypertension is 120 to 480 mg per day administered in a single dose or two divided doses. The hazards (see WARNINGS ) of trandolapril are generally independent of dose; those of verapamil are a mixture of dose-dependent phenomena (primarily dizziness, AV block, constipation) and dose-independent phenomena, the former much more common than the latter. Therapy with any combination of trandolapril and verapamil will thus be associated with both sets of dose-independent hazards. The dose-dependent side effects of verapamil have not been shown to be decreased by the addition of trandolapril nor vice versa. Rarely, the dose-independent hazards of trandolapril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with trandolapril and verapamil hydrochloride extended-release tablets only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other mo…
Warnings
WARNINGS Heart Failure Verapamil Component Verapamil has a negative inotropic effect which, in most patients, is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In clinical experience with 4,954 patients, 87 (1.8%) developed congestive heart failure or pulmonary edema. Verapamil should be avoided in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30%, pulmonary wedge pressure above 20 mmHg, or severe symptoms of cardiac failure) and in patients with any degree of ventricular dysfunction if they are receiving a beta adrenergic blocker (see PRECAUTIONS - Drug Interactions ). Patients with milder ventricular dysfunction should, if possible, be controlled with optimum doses of digitalis and/or diuretics before verapamil treatment (Note interactions with digoxin under: PRECAUTIONS ). Trandolapril Component Trandolapril, as an ACE inhibitor, may cause excessive hypotension in patients with congestive heart failure (see WARNINGS - Hypotension ). Hypotension Verapamil Component Occasionally, the pharmacologic action of verapamil may produce a decrease in bloo…
Contraindications
CONTRAINDICATIONS Trandolapril and verapamil hydrochloride extended-release tablets are contraindicated in patients who are hypersensitive to any ACE inhibitor or verapamil. Because of the verapamil component, trandolapril and verapamil hydrochloride extended-release tablets are contraindicated in: 1. Severe left ventricular dysfunction (see WARNINGS ). 2. Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock. 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). 4. Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). 5. Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g. Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see WARNINGS ). 6. Patients taking flibanserin (see PRECAUTIONS - Drug Interactions ). Because of the trandolapril component, trandolapril and verapamil hydrochloride extended-release tablets are contraindicated in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor. Do not co-administer aliskiren with trandolapril and verapamil hydrochloride ex…
Drug Interactions
Drug Interactions In vitro metabolic studies indicate that verapamil is metabolized by cytochrome P450 including CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. Verapamil has been shown to be an inhibitor of CYP3A4 enzymes and P-glycoprotein (P-gp). Clinically significant interactions have been reported with inhibitors of CYP3A4 (e.g. erythromycin, ritonavir) causing elevation of plasma levels of verapamil while inducers of CYP3A4 (e.g. rifampin) have caused a lowering of plasma levels of verapamil. Therefore, patients receiving inhibitors or inducers of the cytochrome P450 system should be monitored for drug interactions. Ivabradine Concurrent use of verapamil increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Avoid co-administration of verapamil and ivabradine. Digitalis Clinical use of verapamil in digitalized patients has shown the combination to be well tolerated if digoxin doses are properly adjusted. Chronic verapamil treatment can increase serum digoxin levels by 50 to 75% during the first week of therapy, and this can result in digoxin toxicity. In patients with hepatic cirrhosis, the influence of verapamil on digoxin kinetics is magni…
Adverse Reactions
ADVERSE REACTIONS Trandolapril and verapamil hydrochloride extended-release tablets have been evaluated in over 1,957 subjects and patients. Of these, 541 patients, including 23% elderly patients, participated in U.S. controlled clinical trials, and 251 were studied in foreign controlled clinical trials. In clinical trials with trandolapril and verapamil hydrochloride extended-release tablets, no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with verapamil or trandolapril. Trandolapril and verapamil hydrochloride extended-release tablets have been evaluated for long-term safety in 272 patients treated for 1 year or more. Adverse experiences were usually mild and transient. Discontinuation of therapy because of adverse events in U.S. placebo-controlled hypertension studies was required in 2.6% and 1.9% of patients treated with trandolapril and verapamil hydrochloride extended-release tablets and placebo, respectively. Adverse experiences occurring in 1% or more of the 541 patients in placebo-controlled hypertension trials who were treated with a range of t…
Frequently Asked Questions
What is Trandolapril and Verapamil Hydrochloride used for?
Trandolapril and Verapamil Hydrochloride contains Trandolapril and Verapamil Hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Trandolapril and Verapamil Hydrochloride a controlled substance?
Trandolapril and Verapamil Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Trandolapril and Verapamil Hydrochloride?
The generic name for Trandolapril and Verapamil Hydrochloride is Trandolapril and Verapamil Hydrochloride. There are no other listed brand versions of Trandolapril and Verapamil Hydrochloride.
What is the NDC code for Trandolapril and Verapamil Hydrochloride 1 mg/1?
The NDC (National Drug Code) for Trandolapril and Verapamil Hydrochloride 1 mg/1 is 68462-294, listed by Glenmark Pharmaceuticals Inc., USA.
Other Trandolapril and Verapamil Hydrochloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)